ustekinumab FDA label update (2026-06-19)

2 min read Jul 13, 2026, 4:55 PM

Medications Ustekinumab IL-12/23 inhibitor Regulatory Update Adult patients Pediatric Patients Clinicians Patients On Biologics

Why This Matters

This is an FDA drug-label record for ustekinumab that lists approved uses for Crohn’s disease and ulcerative colitis and highlights safety precautions (infections, TB screening, malignancy risk, and vaccine recommendations) relevant to people with IBD or those considering biologic therapy.

Who Should Pay Attention

Adults and children with Crohn’s disease or ulcerative colitis, patients considering or receiving ustekinumab, and clinicians managing biologic therapy.

Study Snapshot

Story typeRegulatory

Evidence typeRegulatory update

Study statusHuman prescription drug

Source depthRegulatory record

What To Know

Ustekinumab (an inhibitor of interleukin-12/23) has an updated FDA drug label listing approved indications across plaque psoriasis, psoriatic arthritis, Crohn’s disease (from age 2 years), and ulcerative colitis (adults).

The label emphasizes infection risks (including TB screening prior to starting), potential malignancy risk, hypersensitivity, and pulmonary events; it also notes avoidance of live vaccines during treatment.

The label update summarizes serious infections observed in trials for several indications (including Crohn’s disease) and gives guidance to evaluate and treat latent tuberculosis before initiating ustekinumab.

It also warns about theoretical infection risks tied to IL-12/IL-23 biology and reports post-approval cases of interstitial and eosinophilic pneumonia. If you are taking or considering ustekinumab, this label is a regulatory reference describing approved uses and safety precautions.

Discuss screening for tuberculosis, vaccination timing, and infection signs with your clinician. The label lists important warnings but does not provide individualized medical advice.

Keep In Mind

This document is a regulatory drug-label update from DailyMed (FDA-sourced). It is authoritative for prescribing information and safety warnings but does not replace personalized medical advice. The extracted text is partial but matches the label sections (Indications and Warnings) provided by the source.

Source Details

Review the original publication for the complete reporting, methods, and context.

Read Original Source

Regulatory update Evidence type derived from source or registry metadata.

PublicationopenFDA

Study typeDrug Label Update

Indexed viaopenFDA

Source typeRegulatory record

PublishedJun 19, 2026, 12:00 AM

Content availableRegulatory record

This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.